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Clinical trials for Teduglutide

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    13 result(s) found for: Teduglutide. Displaying page 1 of 1.
    EudraCT Number: 2016-000849-30 Sponsor Protocol Number: SHP633-304 Start Date*: 2017-07-03
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients with Short Bowel Syndrome Who Completed TED-C14-006 Original PIP P/238/2010
    Medical condition: Short Bowel Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) FI (Completed) IT (Completed) GB (GB - no longer in EU/EEA) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-000863-17 Sponsor Protocol Number: SHP633-303 Start Date*: 2017-03-28
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: A Retrospective and Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Subjects with Short Bowel Syndrome Who Completed TED-C13-003 Original PIP P/238/2010
    Medical condition: short bowel syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-000439-27 Sponsor Protocol Number: CL0600-005 Start Date*: 2007-10-29
    Sponsor Name:NPS Allelix Corporation
    Full Title: A Study of the Safety and Efficacy of Teduglutide in Subjects with Parenteral Nutrition-Dependant Short Bowel Syndrome Who Completed Protocol CL0600-004
    Medical condition: Short Bowel Syndrome (SBS) refers to the clinical situation whereby a significant reduction in the absorptive capacity of the intestine results from inadequate anatomical or functional length of re...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-004588-30 Sponsor Protocol Number: TED-C13-003 Start Date*: Information not available in EudraCT
    Sponsor Name:NPS Pharmaceuticals, Inc.
    Full Title: A 12-Week Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects Aged 1 Year through 17 Years, with Short Bowel Syndrome who are Dependent on Parenteral Support
    Medical condition: Short Bowel Syndrome
    Disease: Version SOC Term Classification Code Term Level
    16.1 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002252-27 Sponsor Protocol Number: TED-C14-006 Start Date*: 2016-09-19
    Sponsor Name:NPS Pharmaceuticals, Inc.
    Full Title: A 24-Week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Through 17 Years of Age with Short Bowel Syndrome who are Dependent ...
    Medical condition: Short Bowel Syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) FI (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-011679-65 Sponsor Protocol Number: CL0600-021 Start Date*: 2010-03-26
    Sponsor Name:NPS Pharmaceuticals, Inc.
    Full Title: A Long Term, Open Label Study with Teduglutide for Subjects with Parenteral Nutrition Dependent Short Bowel Syndrome
    Medical condition: Short Bowel Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) IT (Completed) GB (Completed) DK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2022-003572-16 Sponsor Protocol Number: TAK-633-3008 Start Date*: 2022-12-06
    Sponsor Name:Takeda
    Full Title: A Phase 3, Open-label Safety Study of Teduglutide in Japanese Pediatric Patients With Short Bowel Syndrome Who are Dependent on Parenteral Support, Aged 4 Months of Corrected Gestational Age or Old...
    Medical condition: Short Bowel Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-003606-40 Sponsor Protocol Number: SHP633-301 Start Date*: 2018-05-28
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: A Randomized, Open-label, 24-Week Safety, Efficacy, and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age with Short Bowel Syndrome Who are Dependent on Parenteral Support Orig...
    Medical condition: Short Bowel Syndrome (SBS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) FI (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-005404-36 Sponsor Protocol Number: SHP633-305 Start Date*: 2021-10-19
    Sponsor Name:Shire
    Full Title: A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Japanese Pediatric Subjects with Short Bowel Syndrome Who Completed SHP633-302
    Medical condition: Treatment of short bowel syndrome
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-000438-35 Sponsor Protocol Number: CL 0600-004 Start Date*: 2004-09-30
    Sponsor Name:NPS Allelix Corporation
    Full Title: A study of the Efficacy and Safety of Teduglutide in subjects with Parenteral Nutritional Dependant Short Bowel Syndrome
    Medical condition: Short Bowel Syndrome (SBS) refers to the clinical situation whereby a significant reduction in the absorptive capacity of the intestine results from inadequate anatomical or functional length of re...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2020-005791-35 Sponsor Protocol Number: SHP633-302 Start Date*: 2020-12-23
    Sponsor Name:Shire
    Full Title: A 24-week Safety, Efficacy, Pharmacodynamic, and Pharmacokinetic Study of Teduglutide in Japanese Pediatric Subjects, Aged 4 Months Through 15 Years, With Short Bowel Syndrome Who Are Dependent on ...
    Medical condition: Treatment of short bowel syndrome dependent on parenteral support
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-006193-15 Sponsor Protocol Number: CL0600-020 Start Date*: 2009-06-25
    Sponsor Name:NPS Pharmaceuticals, Inc.
    Full Title: A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects with Parenteral Nutrition-Dependent Short Bowel Syndrome
    Medical condition: Short Bowel Syndrome
    Disease: Version SOC Term Classification Code Term Level
    12.0 10049416 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) ES (Completed) FR (Completed) IT (Completed) GB (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-001405-32 Sponsor Protocol Number: IMIS2017-02 Start Date*: Information not available in EudraCT
    Sponsor Name:Institut des Maladies Génétiques - Imagine
    Full Title: A Monocentric Single-arm study to characterize the long-term safety, efficacy, and pharmacodynamic of GLP-2 analog (Revestive®) in the management of short bowel syndrome pediatric patients on home-...
    Medical condition: Short Bowel Syndrom
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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